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Regulatory Affairs Manager Jobs in Rochester, MN

micro1 AI

Regulatory Affairs Specialist

Rochester, MN · Remote

$50 - $70/hr

Regulatory Affairs Specialist Role Type: Contractor Location: Remote micro1 is engaging Regulatory Affairs Specialists to contribute to a customer's project focused on AI innovation in regulatory ...

micro1 AI

Regulatory Affairs Specialist

Rochester, MN · Remote

$50 - $70/hr

Regulatory Affairs Specialist Role Type: Contractor Location: Remote micro1 is engaging Regulatory Affairs Specialists to contribute to a customer's project focused on AI innovation in regulatory ...

Monarch Shores

Executive Director

Rochester, MN · On-site

$120 - $150/hr

... and Regulatory Affairs. * Collaborate with admissions, revenue, and insurance teams to ensure ... Develop and manage annual budgets, maintaining fiscal responsibility and efficient resource use.

All JobsRegulatory Affairs JobsRegulatory Affairs Manager JobsRegulatory Affairs Manager Jobs in Rochester, MN

Regulatory Affairs Manager information

See Rochester, MN salary details

$29

$57

$87

How much do regulatory affairs manager jobs pay per hour?

As of Aug 12, 2026, the average hourly pay for regulatory affairs manager in Rochester, MN is $57.91, according to ZipRecruiter salary data. Most workers in this role earn between $42.74 and $67.69 per hour, depending on experience, location, and employer.

What does a regulatory affairs manager do?

A Regulatory Affairs Manager oversees the process of ensuring that a company’s products comply with all regulations and laws applicable to their industry, such as pharmaceuticals, medical devices, or food. They coordinate the preparation and submission of regulatory documents to government agencies and serve as a liaison between the company and regulatory authorities. Their role includes monitoring changes in regulations, developing strategies for approval, and ensuring ongoing compliance throughout the product lifecycle.

What are the key skills and qualifications needed to thrive as a regulatory affairs manager, and why are they important?

To thrive as a Regulatory Affairs Manager, you need a comprehensive understanding of regulatory guidelines, scientific or technical expertise, and typically a degree in life sciences or a related field. Experience with submission management systems, regulatory databases, and knowledge of global regulatory frameworks (such as FDA, EMA, or ICH) are highly valuable. Strong attention to detail, communication skills, and the ability to manage cross-functional teams distinguish top performers in this role. These competencies are crucial for ensuring product compliance, minimizing approval risks, and facilitating smooth market entry.

What are some common challenges faced by regulatory affairs managers when working with cross-functional teams?

Regulatory Affairs Managers often encounter challenges in aligning regulatory requirements with the goals of other departments, such as R&D, marketing, and manufacturing. Navigating differing priorities and timelines can be complex, especially when ensuring compliance without delaying product development. Effective communication and negotiation skills are essential to bridge gaps between teams, clarify regulatory expectations, and facilitate smooth collaboration. By proactively engaging stakeholders and providing regulatory guidance early in projects, Regulatory Affairs Managers can help teams work together more efficiently and avoid costly compliance issues.

What does a regulatory affairs manager do?

As a regulatory affairs manager, your responsibilities entail ensuring that your employer observes all relevant laws and regulations. You can find employment in various sectors, including pharmaceutical, healthcare, and manufacturing industries. Your duties include compiling all necessary paperwork, evidence, and documentation to report to regulatory authorities. In addition to the management of paperwork and legal requirements, you help companies make operational and strategic decisions based on the regulations they are obligated to follow. You sometimes perform or coordinate audits to ensure compliance, and, in a large company, you oversee a staff of compliance specialists who handle various regulatory affairs tasks.

What is the difference between Regulatory Affairs Manager vs Regulatory Affairs Specialist?

AspectRegulatory Affairs ManagerRegulatory Affairs Specialist
CredentialsBachelor's degree, often advanced certifications (e.g., RAC)Bachelor's degree, entry-level certifications
Work EnvironmentOversees teams, strategic planning, cross-department collaborationExecutes regulatory submissions, document preparation, detailed compliance tasks
Industry UsageUsed in pharmaceutical, biotech, medical device companies for leadership rolesCommonly found in similar industries, focusing on technical regulatory tasks
Search & Comparison IntentUnderstanding managerial responsibilities and scopeFocus on specific regulatory tasks and compliance details

The Regulatory Affairs Manager typically holds a leadership role, overseeing regulatory strategies and teams, while the Regulatory Affairs Specialist handles detailed compliance work and documentation. Both roles require relevant certifications and are essential in regulated industries like pharma and medical devices.

More about Regulatory Affairs Manager jobs
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What cities near Rochester, MN are hiring for Regulatory Affairs Manager jobs? Cities near Rochester, MN with the most Regulatory Affairs Manager job openings:
Regulatory Affairs Manager jobs near you
Infographic showing various Regulatory Affairs Manager job openings in Rochester, MN as of August 2026, with employment types broken down into 82% Full Time, 17% Part Time, and 1% Contract. Highlights an 84% Physical, 2% Hybrid, and 14% Remote job distribution, with an average salary of $120,447 per year, or $57.9 per hour.

Regulatory Affairs Specialist

micro1 AI

Rochester, MN • Remote

$50 - $70/hr

Part-time

Posted 8 days ago

Job description

Role Title: Regulatory Affairs Specialist


Role Type: Contractor


Location: Remote


micro1 is engaging Regulatory Affairs Specialists to contribute to a customer's project focused on AI innovation in regulatory documentation. In this role, you'll apply your expertise to help train next-generation AI systems. Your work will shape how models learn, reason, and perform through high-quality, real-world input. No prior experience in AI is required — your domain knowledge is what matters.


Scope of Work

  1. Author and review evaluation tasks inspired by real-world agency requests and sponsor response threads, determining if drafted responses meet regulatory expectations.
  2. Apply expert judgment to review clinical documentation, assessing whether conclusions are substantiated, commitments are properly scoped, and records can withstand regulatory scrutiny.
  3. Distinguish between substantively adequate and superficially polished responses, articulating clear rationales for any deficiencies.
  4. Assess consistency across comprehensive document sets, identifying unsupported or conflicting claims within or between documents.
  5. Provide structured, well-reasoned written feedback grounded in applicable regulatory guidelines rather than subjective impressions.
  6. Collaborate asynchronously and communicate complex regulatory concepts clearly in both written and verbal form.


Preferred Qualifications

  1. 5+ years of direct regulatory affairs experience at a sponsor, CRO, or consultancy, with responsibility for clinical submissions.
  2. Documented experience drafting or leading responses to health authority information requests, particularly for ongoing regulatory filings.
  3. Demonstrated working knowledge of the ICH framework, CTD/eCTD structure, and practical expectations of at least one major regulatory body (FDA, EMA, MHRA, PMDA, or Health Canada).
  4. Proven ability to critically read clinical or safety documents to identify regulatory risks, unsupported statements, and potential reviewer concerns.
  5. Exceptional written communication skills, with the capability to convey regulatory reasoning clearly, concisely, and defensibly.
  6. Degree in life sciences, pharmacy, medicine, or a related field; RAC certification is an advantage.
  7. Experience engaging with multiple regions or agencies, prior health authority reviewer/assessor background, or familiarity with AI-assisted regulatory tools (all considered valuable).

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